Pharming Group reports financial results for the first quarter of 2021

      Financial highlights Operational highlights Post-period operational highlights Chief Executive Officer, Sijmen de Vries, commented: "As previously experienced, the progression of the COVID-19 pandemic has resulted in quarterly fluctuations in revenue. Results in Q1 2021 were negatively affected in the US by a severe COVID-19 surge at the end of 2020 and into 2021. "This caused overstocking of RUCONEST ®  in Q4 2020 and physician office closures...

 

 

Financial highlights

Operational highlights

Post-period operational highlights

Chief Executive Officer, Sijmen de Vries, commented:

"As previously experienced, the progression of the COVID-19 pandemic has resulted in quarterly fluctuations in revenue. Results in Q1 2021 were negatively affected in the US by a severe COVID-19 surge at the end of 2020 and into 2021.

"This caused overstocking of RUCONEST® in Q4 2020 and physician office closures well into Q1 2021, which resulted in reduced patient visits and slower annual prescription renewals. The combination of these factors in Q1 2021 led to lower prescription refill rates by patients still using additional RUCONEST® stock and a reduction in new patient enrollment.

"Positively, towards the end of Q1 2021, these trends started to reverse. We were also able to resume some face-to-face sales and marketing activities due to the rapid roll-out of COVID-19 vaccinations in the US.

"As a result, we realized a significant increase in new patient enrollment at the end of Q1 2021. This increase has continued into Q2 2021 and we expect sales to continue to recover over the quarter, subject to any further surges in COVID-19 cases.

"Outside of the US, demand remained stable, but growth was affected by travel restrictions and lockdowns still in place in most EU markets.

"In our pipeline, we continued to progress activities for the anticipated launch of leniolisib in Q4 2022, including an important collaboration to offer US immunologists access to free genetic testing for primary immune deficiency patients exhibiting APDS symptoms.

"In addition, post period end, we announced the start of our Phase IIb study in acute kidney injury as we continue to investigate the treatment potential of RUCONEST® in further indications."

Outlook

For the remainder of 2021, the Company expects:

No further specific financial guidance for 2021 is provided.

As previously announced, as of 1 January 2021, the Company changed its presentation currency from Euro to US Dollar. 

About Pharming Group N.V.

Pharming Group N.V. is a global, commercial stage biopharmaceutical company developing innovative protein replacement therapies and precision medicines for the treatment of rare diseases and unmet medical needs.

The flagship of our portfolio is our recombinant human C1 esterase inhibitor (rhC1INH) franchise. C1INH is a naturally occurring protein that down regulates the complement and contact cascades in order to control inflammation in affected tissues.

Our lead product, RUCONEST®, is the first and only plasma-free rhC1INH protein replacement therapy. It is approved for the treatment of acute hereditary angioedema (HAE) attacks. We are commercializing RUCONEST® in the United States, the European Union and the United Kingdom through our own sales and marketing organization, and the rest of the world through our distribution network.

In addition, we are investigating the clinical efficacy of rhC1INH in the treatment of further indications, including pre-eclampsia, acute kidney injury and severe pneumonia as a result of COVID-19 infections.

We are also studying our oral precision medicine, leniolisib (a phosphoinositide 3-kinase delta, or PI3K delta, inhibitor), for the treatment of activated PI3K delta syndrome, or APDS, in a registration enabling Phase 2/3 study in the United States and Europe.

Furthermore, we are leveraging our transgenic manufacturing technology to develop next-generation protein replacement therapies, most notably for Pompe disease, which is currently in preclinical development.

For further information please visit: www.pharming.com  

Forward-looking Statements

This press release contains forward-looking statements, including with respect to timing and progress of Pharming's preclinical studies and clinical trials of its product candidates, Pharming's clinical and commercial prospects, Pharming's ability to overcome the challenges posed by the COVID-19 pandemic to the conduct of its business, and Pharming's expectations regarding its projected working capital requirements and cash resources, which statements are subject to a number of risks, uncertainties and assumptions, including, but not limited to the scope, progress and expansion of Pharming's clinical trials and ramifications for the cost thereof; and clinical, scientific, regulatory and technical developments. In light of these risks and uncertainties, and other risks and uncertainties that that are described in Pharming's 2020 Annual Report and the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission, the events and circumstances discussed in such forward-looking statements may not occur, and Pharming's actual results could differ materially and adversely from those anticipated or implied thereby. Any forward-looking statements speak only as of the date of this press release and are based on information available to Pharming as of the date of this release.

Inside Information

This press release relates to the disclosure of information that qualifies, or may have qualified, as inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation.

For further public information, contact:

Pharming Group, Leiden, The Netherlands
Sijmen de Vries, CEO: T: +31 71 524 7400
Susanne Embleton, Investor Relations Manager: T: +31 71 524 7400 E: [email protected]

FTI Consulting, London, UK
Victoria Foster Mitchell/ Alex Shaw/ Amy Byrne
T: +44 203 727 1000

LifeSpring Life Sciences Communication, Amsterdam, The Netherlands
Leon Melens
T: +31 6 53 81 64 27
E: [email protected]

Pharming Group N.V.
Condensed Consolidated Interim Financial Statements in US Dollars (unaudited)
For the period ended 31 March 2021

Appendix: Main condensed consolidated Interim Financial Statements reported in Euros
(This appendix is not part of the Condensed Consolidated Interim Financial Statements)

 

 

 

Appendix: Main Condensed Consolidated Financial Statements reported in Euro's

These statements are not part of the original Interim Financial Statements. The original Interim Financial Statements are reported in US Dollars. In case of differences of interpretation between the Financial Statements in US dollars and the Financial Statements in Euros, the Financial Statements in US Dollars will prevail.

 

 

 

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